The FDA has waved the green regulatory flag for Merck's new asthma drug Dulera, a two-in-one fixed-dose combo drug that is also being studied for chronic obstructive pulmonary disorder. Dulera combines mometasone furoate and formoterol fumarate, which Merck acquired in its buyout of Schering-Plough.
"Asthma control is an important treatment goal and Dulera provides a new option for physicians to help manage this chronic condition in appropriate patients," said S. Blaiss, M.D., clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center. The drug was approved for use among patients 12 and older.
Dulera spurs a dual action as both an inhaled corticosteroid and a long-acting beta agonist, which has raised some safety concerns that may have slowed the agency's approval process, according to Reuters.
- read the Merck release
- here's the story from Reuters